Avinger(AVGR)2023-03-16 01:15Financial Data and Key Metrics Changes - Total revenue for Q4 2022 was 2.3 million in Q3 and 4.2 million, relatively stable compared to 5 million in Q4 2021 [22] Business Line Data and Key Metrics Changes - Pantheris image-guided atherectomy products showed growth, with both Pantheris 7 French and Pantheris SV devices each growing 6% sequentially [8] - The Pantheris SV device is now the largest selling product, primarily used for treating below-the-knee lesions [9][10] Market Data and Key Metrics Changes - CMS increased outpatient reimbursement in hospitals by 4% to 5% while decreasing atherectomy reimbursement in Office Based Labs by approximately 6%, which is seen as a net positive for the company since 90% of revenue comes from hospital accounts [9] Company Strategy and Development Direction - The company launched the Lightbox 3 imaging platform, enhancing capabilities and efficiency in engaging with accounts [6] - Plans for 2023 include launching two new products: Tigereye ST for CTO crossing and Pantheris LV for atherectomy, which are expected to expand the addressable market [15][19] - The company is focused on increasing case coverage capability, driving new account activity, and completing regulatory approvals for new devices [19] Management's Comments on Operating Environment and Future Outlook - Management noted that while the direct impact of COVID has lessened, staffing shortages continue to affect procedure availability [8] - The company is optimistic about the potential of its proprietary OCT-guided approach to revolutionize the coronary market [7][16] Other Important Information - Cash and cash equivalents totaled $14.6 million as of December 31, indicating a strong financial position to fund strategic initiatives [22] - The company is conducting a post-market clinical study called Image BTK to evaluate Pantheris SV, with promising interim results [11][12] Q&A Session Summary Question: Confidence in approval of Tigereye ST and Pantheris LV - Management expressed confidence in nearing the end of the review process for Tigereye ST and anticipates clearance by mid-year for Pantheris LV, pending FDA review [25] Question: Commercialization strategy for new products - Both products will undergo a limited launch to gain clinical experience and support for physicians before a full commercial launch [27] Question: Learnings from Lightbox 3 usage - The new Lightbox 3 has accelerated new account acquisition and has been well-received by existing physicians due to its advanced imaging capabilities [29] Question: Timeline for starting clinical programs for coronary CTO product - The goal is to initiate clinical studies in 2024, following the completion of design selection and verification processes [31]